And I'm very excited to be going over some of the bariatric endoscopy cases today. So I'm just curious, out in the audience, who have had some experience with bariatric endoscopy? Awesome, all right, so we're gonna do some questions and answers throughout the talk today. So feel free to interrupt, ask questions. We're gonna go slow, go over a few cases today. Here are my disclosures. And the goals for the talk today is to help you understand the cognitive aspects of bariatric endoscopy, indications, contraindications, as well as some technical aspects of the currently available endoscopic bariatric procedures. All right, let's start with the first case. Here we have a 48-year-old woman, history of class one obesity, BMI 33, type two diabetes, her A1C was 7.5%, and AFib on Coumadin. And she comes into your clinic wanting to lose weight. Which treatment option would you recommend her? Is it intragastric balloon, endoscopic sleeve gastroplasty, duodenal jejunal bypass liner, or duodenal mucosal resurfacing? Who said A? All right, we have one, two. What about ESG? Pretty popular, we heard about ESG. Who wants to do ESG here? Okay, we got five people. What about small bowel procedures? Endo-barrier, fractal, she has diabetes, should we offer that? No one. All right, so here we should consider a balloon. And the reason for not offering an ESG is because she's on Coumadin. This is a relative contraindication for an ESG. We're gonna be taking 80 bites in the stomach, so you don't want her to go back, get on Coumadin, and then bleed. The last two options, the small bowel interventions are available, but it's only part of a U.S. trial. And the patients have to have an A1C of either 7.5 or 8.5 and above. Depending on what part of the country you live in, that could also be considered a normal BMI. But, you know, like, the excess of BMI of 33 is generously paid. You can still offer a balloon, though. How about POSE? POSE procedure? POSE you can consider, good answer, but it's not on the answer choices. All right, so when we talk about primary bariatric endoscopic procedures, usually we divide them up into gastric and small bowel interventions. In general, when we talk about gastric interventions, these procedures have a primary effect on weight loss with secondary effects on metabolic outcomes. In contrast, when you look at small bowel interventions, the procedure have a primary effect on metabolic conditions with or without weight loss. Right now in the U.S., we have three endoscopic devices or procedures that are available, and these are Orbera intragastric balloon, ESG, or POSE. And we're gonna go over them today. Let's start with a balloon. So these are the four relevant balloons in the U.S. On the left, Orbera balloon. This is fluid-filled, FDA-approved, and commercially available. So this is probably what you've heard of the most. Obalon, gas-filled, FDA-approved, but it's no longer commercially available due to financial constraints of the company. Spas balloon, fluid-filled, but the unique thing is that it's adjustable, so you can make the volume bigger for more weight loss or smaller so that patients can tolerate the balloon. It's FDA-approved last year. However, it's still undergoing a post-approval study, so not commercially available. And then the last balloon, Allurin balloon. This is fluid-filled and procedure-less, so the patients swallow the balloon. Four months later, it self-dissolves in the stomach, so you don't have to do any endoscopy at all. It's still undergoing a pivotal trial. So let's look at OBR balloon. So it's approved for patients with a BMI between 30 and 40. You place it with endoscopy and remove it with endoscopy at six months. Contraindications include a large hiatal hernia, peptic ulcer disease, and any types of prior gastric surgery. You should not offer a balloon. All right, so let's look at the placement. It's pretty simple. So you pass the balloon catheter into the mouth, pass a scope next to it, make sure that the balloon is within the stomach, and then start filling the balloon. So here I'm showing you how to fill the balloon. I'm showing the balloon outside the stomach here, but you see that you can connect one tip of the balloon catheter to a syringe, or you can hook it to the water pump, and then just start filling it with normal saline and methylene blue. Once you get to the desired volume, you just pull the catheter gently, and that will detach the balloon. What about the data? So here's a meta-analysis from the ASGE looking at 17 studies and 1,600 patients with ovarian balloon. The data show that at one year, so six months after balloon removal, patients had about 10% total weight loss. In terms of SAE, patient had perforation rate 0.1%. All of these patients had prior gastric surgery, and mortality rate was 0.08% from either a perforation or aspiration. All right, case continue. So she came back three months later, and she complained of acute onset abdominal pain, nausea, and vomiting. At that time, she's at about 10% total weight loss at three months. We obtained a KUB which shows the finding on the right side. What do you think she has? Rapid weight loss, hyperinflation, small bowel obstruction, or balloon relocation into the fundus. Who said A? No one. B, hyperinflation. Many hands. And small bowel obstruction. And last one, balloon sitting in the fundus. Awesome, so everyone got it. So it's hyperinflation. And the key here is the air fluid level. And the balloon sitting in the fundus is actually quite normal. It can sit in the body of the stomach. So hyperinflation is thought to be due to microbial overgrowth of the fluid inside the balloon. And the treatment is actually balloon removal. So you talk with her. She agree that, okay, we can remove the balloon. I got 10% total weight loss already. However, you realize that you do not have a balloon removal kit in your endoscopy suite. What do you do? Any thought, any idea, like how we can remove this balloon? Someone show this. Poke the balloon. Exactly. So you know, we're an advanced endoscopist. We love FNA needles. So let's try an FNA needle. So what I do here, I use a double channel endoscope with an FNA, 19 gauge FNA needle. All right, so let's look. So you see the air fluid level here. So now I'm gonna advance the catheter of the FNA needle and put it next to the balloon. And then advance the needle to puncture the balloon. Then you advance the catheter over the needle, withdraw the needle, and then you can hook the top of the FNA needle to the wall suction. And you just sit there and wait until the balloon is completely deflated. Another way of doing it, and I do have experience with that because I've placed a lot of balloons. When you don't have the kit, the kit is the easiest, but we don't have the kit. The FNA needles are quite expensive. And outside the US, many people cannot afford them. So a good way of doing it is using a needle knife. You can use a needle knife, put it inside, remove the knife itself and the catheter, and then you can aspirate it. If you think there is some extravasation ahead of time, the patient needs to be intubated because I've heard of cases where the fluid would gush out and patient would aspirate. There is about 700 CCs of liquid inside the balloon. So it's a large amount. Totally, totally agree. When you want to remove a balloon, we always intubate the patient. Placement, you can do it with MAC, but during removal, because of possible aspiration and when you want to pull the balloon out, intubation is key. I'm sorry, we don't do that. And again, it's conscious sedation or deep sedation for removal. If you have the kit, it's very unusual to have a problem. So we never intubated patients on the way, except if you don't have the kit and you want to go to alternative plans. And we do have experience on more than 2,000 cases over 10 years. And we've never intubated a patient while we're removing the balloon. So it can be done safely if you have the kit, but if not, then probably it's a better idea to do that. Yeah, yeah. To clarify that, we do not have the balloon removal kit. All right, so. Do you have to put a catheter in and suction everything out? Or could you theoretically just rupture the balloon and let it all spill into something and suck it out? You won't get the whole fluid out. If you just let it kind of let go, you won't get it. So you need the wall suction. All right, so then once you have the deflated balloon here, I use forceps through the snare technique. Let me continue here. And you want to make sure that you completely, completely deflate the balloon before you remove it. So now you grab it with a snare, you have the forceps, you pull it to the tip of the scope, and then you pull everything out. So this is one possible technique. Obviously, there are multiple techniques that you can kind of revise and use your endoscopy tool to remove this balloon. All right, so let's move on to case two. So here's a 36-year-old woman, history of class III obesity, BMI 41. She has GERD, heel grade III hiatal hernia. And now she comes in wanting to lose weight. Which treatment option would you recommend? Is it a balloon, ESG, duodenal jejunal bypass liner, or sleeve gastrectomy? All right, who said balloon? ESG? Multiple hands for ESG. What about endobarrier? A few hands. And what about sleeve gastrectomy? Her BMI is 41. Okay, so I think we have a split here. So here, we think ESG might be best for her. And the reason is, balloon patients have heel grade III. So this is a large hernia, so it's a contraindication for an intragastric balloon. Again, for endobarrier, this is only offered for patients with diabetes with A1C of eight to 10%. And sleeve gastrectomy is a good option because her BMI does qualify. However, she has acid reflux, and this is a relative contraindication because it's been shown that after sleeve gastrectomy, patients may have de novo GERD in about 20%. All right, let's look at ESG in the United States. Currently, we have three endoscopic suturing or placation devices that are cleared by the FDA for tissue approximation. On the left is the overstitch by Apollo. I think this is what we're most familiar with. This device actually recently received de novo authorization for obesity and also weight gain. So this is more unique compared to the other two devices, and it's widely commercially available. In the middle is the IOP device from USGI. It's a placation device, and right now, it's undergoing a US pivotal study. It's available at limited centers. And then on the right is the endomena placation device, and this device was approved, cleared last year, and it's undergoing a pilot study, so it's not commercially available yet. All of these devices can be used to perform an endoscopic sleeve. All right, history of ESG. So this procedure was first performed by our mentor, Dr. Chris Thompson and Rob Halls in 2012, so 10 years ago now. And at that time, it was fortunate to be a medical student in the case documented the suture pattern of the very first ESG in the world. All right, so the OverStitch device comes in two forms. The original OverStitch is attached to a double-channel scope, and the more recent one that comes out can be compatible with any single-channel EGD scope. So now, when you talk about ESG, if you talk to 10 people, you're gonna get 10 different suture patterns of how people do ESG. This is the pattern that we like the most and that we currently use, and you can see that it's a combination of a U-pattern, an I, or interrupted pattern. But basically, the concept here is that we wanna reduce the width of the stomach and also shorten the length of the stomach. So here, we're gonna look at a video. And you can see, this is the blue line here. So we start with a running suture pattern. So I start at the incisor on the anterior wall of the stomach, and then after the first bite, you start moving down along the greater curvature, and then move down along the greater curvature until you end at the posterior wall, and then cinch. So usually, it's five or six bites for the first suture. And here, you can see that the lumen is already more narrow. After that, I'm gonna start a U-pattern. So this is the yellow line here. Again, you start at the anterior wall, come down along the greater curvature. And once you get to the posterior wall, you move up a little more proximally, and this bite will help shorten the stomach. And then after that, you're gonna start climbing up from the posterior wall and gradually go up along the greater curvature, and then end on the anterior wall. So this is a U-pattern. And the U-pattern, as you can see here, it helps narrow the stomach here and also shorten the stomach. So it does both. All right, so now we cinch, and after that, I'm gonna move to an interrupted reinforcement medially. So I take one bite on the anterior wall, and then the second bite on the posterior wall, and this helps protect the U, or reinforce the U, and also narrow the stomach. And you can see the lumen here. And then you just keep repeating that, keep coming up proximally, and then end at the junction between the gastric body and the fundus. And this is the final look of our ESG here. All right, so let's do some troubleshooting. So during the case, this is an ESG case, this happens. All right, you see I take the bite on the anterior wall, and it's oozing nonstop. So, bleeding. So bleeding is more common on the lesser curvature and the fundus. So those are the areas that you wanna avoid sewing. If that happens, you can apply tension on the suture to tamponade. However, if it happens after the first bite, then you wanna take one more bite, and then apply tension, and then cinch. And usually, most of the time, the bleeding stops. All right, second scenario. All right, so you take a bite, and now you attempt to remove the tissue helix. However, it gets stuck. What should we do? You just pull hard? What do we do? Pull harder? All right, so this usually happens because sometimes your assistant may turn the helix too much in either direction, clockwise, counterclockwise, or sometimes after multiple uses, kind of like at the end of an ESG, sometimes the helix may be bent, and this may happen. So if it happens, you can try turning the helix clockwise. If it doesn't work, counterclockwise. And then worse comes to worse, one technique is by advancing the needle pickup to apply counterpressure. And you can see, we can see here on the right, so that's the needle pickup. You apply it so you can counterpressure, and then you close the helix so that the plastic side is actually sitting on the tissue, and then pull it gently. And then after you pull it, you wanna look, and you might wanna consider over-sewing to close the perforation. All right, this is the third one. So you finish the U here, and now you're singeing your U pattern. And after singeing, you see this. Everything opens up, right? You just place 12 stitches for that U, and then everything opens up. Loose stitches, all right? This happens because the singeing device breaks, and it may break if it's not being straight, if it's not being kept straight when you're singeing, or if your assistant performed the singeing step too abruptly. If this happens, you never leave the loose suture in the patient's body, because that is a cause of a leak, right? You just placed 12 holes in the stomach, and you're not singeing it tightly, so patients go home, leak is gonna happen. So you wanna cut that suture, remove it, and then re-sew at all of the 12 places that you just stitched. All right, so let's look at some ESG data. So this is exciting. This is the most recently published data on ESG. It's the first RCT on endoscopic sleeve versus moderate lifestyle modification. Nine centers in the U.S., 200 patients, and we found that ESG patients got about 13.6% total weight loss, compared to 0.8%, and SAA rate was 2%, including abdominal abscess, upper GI bleeding, and malnutrition. If you look at real-world data, this is a meta-analysis looking at eight observational studies, 1,700 patients. The efficacy was 16% total weight loss, and this is more consistent with real-world data. What about long-term data? So this is a study from Reem Chariah. She looked at her patients, 216 patients, and of these, 38 patients were eligible for five-year follow-up, with a follow-up rate of 82%, and she found that patients were able to maintain the weight loss of about 15%, up to five years. All right, you know what? Because we're in the third space, endoscopy form, sorry, sorry, we're running out of time, as we often do. Ah. And unless Peter wants to give up his time. You're the director, you decide. No, Peter should do it. Peter should do it. Peter, we can't pass up Peter Dragunov at the podium. It's not possible. Sorry, because we're already, as often happens, sorry. Oh, no worries. At 10.40, we're supposed to end this session, go to the next session. Can you show this video to Peter? Yeah. Question and answers ended at 10.40, we can go 10 minutes late. Yeah, play the video while I ask the question. So, play the video and. Okay, we'll play the video and then we'll end here. Get Peter up here. We don't want to forgo Peter. We can't forgo Peter. So, this is the newest ESG version where we combined third space endoscopy with bariatric endoscopy. And you can see we add the step with pylorus-bearing entromyotomy, similar to GPOM, but we do not cut the pyloric muscle. And the concept here is that we think that ESG works by delaying gastric emptying. Therefore, if you cut the muscle in the antrum, you actually can impair the antral pump and further delay gastric emptying and patients may have more weight loss. So, that's the concept. So, we're just gonna show the video here. You see this is at the antrum. We do a mucosal incision and then do submucosal tunneling. Here we use a hybrid knife from Irvi, T-type. And you want to stop in front of the pylorus, right? You don't want to take the pylorus down because then you end up making emptying faster. And then you do myotomy here. You can do full thickness or you can do partial thickness. And then you sew the mucosotomy site closed with endoscopic suturing. So, that's the added step. And then after that is the standard ESG after this. Are you trying to induce gastroparesis? Yes. Okay. But we do have data with the GCSI. So, pop patient for the future? Pop, yeah. Pop, yeah. We're hoping to convince you and Dr. Dragunov to do this procedure. So, this is our preliminary data, six patients. Half of them got partial thickness and then the other half got full thickness myotomy. Tunnel length was nine centimeters. Myotomy length was seven centimeters. And at three months, patients got about 15% total weight loss and we just looked at our six months data and patients were at about 18% total weight loss. No SAEs. And we looked at gastric emptying rate. Everyone was at about 15% total weight loss. Everyone had more delay gastric emptying. But when we follow their GCSI, their GCSI score did not change significantly. All right. Thank you very much. And. Thank you. Okay.

bariatric endoscopy

intragastric balloon

endoscopic sleeve gastroplasty

devices used

efficacy of ESG

third-space endoscopy